Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
Healthy Volunteers
NCT05300971

Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults

Led by University of Colorado, Boulder · Updated on 2025-04-29

150

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to determine the effects of \~12 weeks of repeated hot water immersion ("heat therapy") vs. thermoneutral water immersion on blood pressure and vascular function in late middle-life to older (≥40 years) adults. The study also aims to determine the effects of \~12 weeks of heat therapy on fluid cognitive and cerebrovascular function.

CONDITIONS

Official Title

Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent (no clinical diagnosis of dementia or related diseases AND mini mental state exam score >20).
  • Willing to accept random assignment to intervention.
  • Aged 40 years or older.
  • Premenopausal women must not be pregnant (confirmed by urine pregnancy test).
  • Casual systolic blood pressure between 115 and 159 mmHg.
  • Sufficiently healthy to undergo heat stress as determined by study physicians based on medical history, physical exam, blood tests, and ECG.
  • Ability to refrain from certain dietary supplements, anti-inflammatory medications, and prescription medications prior to testing and water immersion visits if required.
  • Weight stable in the prior 3 months (≤ 2 kg weight change) and willing to remain weight stable during the study.
  • Willing to maintain physical activity, diet, and lifestyle factors for the entire 6-month study duration.
  • Free from alcohol dependence or abuse as defined by DSM-IV.
Not Eligible

You will not qualify if you...

  • Taking three or more anti-hypertensive medications.
  • Systolic blood pressure 140-159 mmHg but not on anti-hypertensive medications unless approved by primary care provider.
  • Regular vigorous aerobic/endurance exercise: more than 4 sessions per week over 30 minutes at workload over 10 METS.
  • Body mass index (BMI) over 40 kg/m2.
  • Current use of anticholinergics, alpha-blockers, or beta-blockers.
  • Current use of certain prescription medications at doses that may interfere with heat stress, including nitrates, nitrites, PDE5 inhibitors, amphetamines, insulin, and thyroid medications, unless approved by study physicians.
  • Orthostatic hypotension as defined by a significant drop in blood pressure upon standing.
  • Active, untreated atrial fibrillation or flutter.
  • Unstable cardiovascular diseases such as unstable angina or recent heart attack or stroke.
  • Recent major health change within 3 months including surgery or significant infection.
  • Open wounds, skin lesions, or history of skin sensitivity to prolonged water immersion or pool chemicals.
  • Blood donation within the past 2 months unless willing to delay study start.
  • Inability to tolerate blood draws or intravenous catheters including history of fainting during blood sampling.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Colorado Boulder

Boulder, Colorado, United States, 80309

Actively Recruiting

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Research Team

V

Vienna E Brunt, PhD

CONTACT

B

Brendan W Kaiser, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults | DecenTrialz